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FITNET Trial: Effectiveness of internet-based CBT for CFS: an RCT (Nijhof et al, '12)

user9876

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I doubt PACE will use employment outcomes as a criterion for recovery. The results were stark. For example, the mean (SD) of lost employment days in the PACE Trial over 12 months was: CBT = 151.0 (108.2), vs, SMC = 141.7 (107.5). "There was no clear difference between treatments in terms of lost employment." Assuming normal distribution, this would suggest that about 85% of the CBT group were losing a minimum of 42 days per year of work, making the [mean -1SD] rule here as ridiculous as it was when used for "normal" fatigue and physical function which was far from recovery. However, use of the [mean -2SD] rule is impossible here due to a large SD.

Perhaps a reasonable compromise may be a threshold based on the maximum number of sick days allowed in full time employment, although this fails to account for work quality (same problem with school attendance) and type of work (participant may have downgraded their career to compensate for limitations). However, if a participant meets full criteria for "recovery" as per prior protocol (which they may have changed since then), *and* is working full-time, well their health may still not be perfect and actigraphy would have been nice, but this is still substantially better than the dubious threshold for "normal" fatigue and physical function. I would happily take that "recovery".

I would still like to know how many GET participants reached the goal of 30-45 minutes of moderate intensity exercise at least 5 times per week. Objective outcomes for fitness may also help determine who is "recovered". Just look at the buff hamster on the exercise wheel in my current avatar, *that* is what GET participants should be like after the 2.5 year followup from baseline if the primary "deconditioning" model of CFS has much relevance.
I was wondering what these work loss figures mean when benefit take up also increases. To lose work days persumably you need to be employed. But with income benefits increasing persumably as well as losing work days people were also working less hours (or not at all).
 
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I doubt PACE will use employment outcomes as a criterion for recovery. The results were stark. For example, the mean (SD) of lost employment days in the PACE Trial over 12 months was: CBT = 151.0 (108.2), vs, SMC = 141.7 (107.5). "There was no clear difference between treatments in terms of lost employment." Assuming normal distribution, this would suggest that about 85% of the CBT group were losing a minimum of 42 days per year of work, making the [mean -1SD] rule here as ridiculous as it was when used for "normal" fatigue and physical function which was far from recovery. However, use of the [mean -2SD] rule is impossible here due to a large SD.

Perhaps a reasonable compromise may be a threshold based on the maximum number of sick days allowed in full time employment, although this fails to account for work quality (same problem with school attendance) and type of work (participant may have downgraded their career to compensate for limitations)
For the UK, the average sickness rate (weighted to match age and sex make-up of PACE) is around 6 days per year, which might provide a useful benchmark.
 

WillowJ

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I thought I already mentioned this but I couldn't find it. 90%+ school attendance is not good enough for "recovery". During the first few years of symptoms, I was fortunate enough to be able to push on and my school attendance did not generally dip below that. However, it was difficult staying adequately alert and academic performance gradually worsened until I was struggling to pass. At that stage in my life, CBT may have helped certain psychosocial consequences of symptoms, but could have also altered my perceptions about "fatigue" and "physical function" in ways which did not reflect reality.

That said, I would have probably still been within normal range for physical function at the time, but at the cost of increased symptom burden which eventually lead to a permanent decline in physical function.
I agree. I managed 98% school attendance while I was attempting to attend school, but I was often not able to keep up with the rest of the class as regards, say, completing assignments.

During some of those times, I would have been unable to attend CBT (schedule too full just trying to attend school & required activities [some number of concerts, etc.]--no extras except church on Sunday). But I was already using great coping styles (and by what others said to me I was able to verify the accuracy of my assessment). Some of it was a bit too good of coping some years :lol: and I was ignoring serious signs and symptoms which should have been checked out, but that would suit Nijmegen just fine. (I'd probably have been diagnosed with POTS or NMH or SVT, had I gone to the doctor at that point, supposing the doc had been any good.)

I also have never recovered the considerable amount of function I lost while pushing myself to attend university.

sorry that you also had this difficulty, BP.
 

Dolphin

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Just to highlight, for what it's worth, the letters said:


"students might have foregone extracurricular activities to attend school.5"
and
Information from actigraphy is essential to ascertain whether the recovered CFS patients are truly well or if they have adapted their lives and are engaging in less high-intensity activity (such as sports and dancing) than their healthy peers.
 

Esther12

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http://jamia.bmj.com/content/early/2012/10/12/amiajnl-2012-001175.abstract?papetoc

Pardon the bump. I've not read this paper, but thought that it could be worth posting the abstract here for potential future reference.

J Am Med Inform Assoc doi:10.1136/amiajnl-2012-001175
  • Review

Internet-based randomized controlled trials: a systematic review

  1. Erin Mathieu1,
  2. Kevin McGeechan1,
  3. Alexandra Barratt1,
  4. Robert Herbert2
+ Author Affiliations
  1. 1Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  2. 2The George Institute for International Health, University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Erin Mathieu, Sydney School of Public Health, University of Sydney, Edward Ford Building (A27), Sydney, New South Wales, Australia, 2006; e.mathieu@uws.edu.au
  • Received 21 June 2012
  • Accepted 14 September 2012
  • Published Online First 13 October 2012
Abstract

Background The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two.
Objective To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality.
Methods A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out.
Results 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%).
Conclusions It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods.
 

Dolphin

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FWIW, the paper has been summarised in some way by Esther Crawley for another journal. I don't know what is said.
Internet-based cognitive behavioural therapy (FITNET) is an effective treatment for adolescents with chronic fatigue syndrome.Crawley EM.Arch Dis Child Educ Pract Ed. 2012 Sep 5. [Epub ahead of print] No abstract available. PMID: 22952037 [PubMed - as supplied by publisher]
I have just found that if I go to Google Scholar http://scholar.google.com/ and enter:
“Internet-based cognitive behavioural therapy (FITNET) is an effective treatment for adolescents with chronic fatigue syndrome”
And then click on the EC paper, one gets a preview which includes all the text of the piece (it cuts off after 3 references).

The image is a bit small but with Internet Explorer, and probably some other browsers, one can zoom in and then it’s fairly legible.
Alternatively save the jpg image and zoom in on it.

It doesn't work for me if I just paste the link into my browser so I won't do that.

I didn't find it very exciting.
 

Esther12

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Turns out it was all hype over nothing.

Statistically insignificant difference between the two groups at follow up. It seems that this criteria for CFS in adolescents captures a lot of people who just get better over time. They've got 'treatments' which can encourage people to answer questionnaires a bit differently for a while... and we're not grateful enough for them.

I wonder if this new is going to be hyped by the Science Media Centre? Lots of coverage last time: http://forums.phoenixrising.me/inde...cfs-an-rct-nijhof-et-al-12.14931/#post-243393

lol at the psychosocialists whinging about not receiving enough positive media coverage for their 'evidence based' treatments.

Internet-Based Therapy for Adolescents With Chronic Fatigue Syndrome: Long-term Follow-up

  1. Sanne L. Nijhof, MDa,
  2. Loudy P. Priesterbach, BSca,
  3. Cuno S. P. M. Uiterwaal, MD, PhDb,
  4. Gijs Bleijenberg, PhDc,
  5. Jan L. L. Kimpen, MD, PhDa, and
  6. Elise M. van de Putte, MD, PhDa
  1. aDepartment of Pediatrics, Wilhelmina Children’s Hospital, and
  2. bJulius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, Netherlands; and
  3. cExpert Centre for Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Abstract

OBJECTIVE: Cognitive behavioral therapy (CBT) is known to be an effective treatment of adolescents with chronic fatigue syndrome (CFS), but its availability is limited. Fatigue in Teenagers on the Internet (FITNET), an Internet-based CBT program for adolescents with CFS, has been developed as an alternative to face-to-face CBT. Recently, its short-term effectiveness has been proven in a randomized clinical trial. Here we aimed to assess the long-term outcome of CFS in adolescents after FITNET treatment and after usual care. In addition, factors related to recovery at long-term follow-up (LTFU) for adolescents treated with the FITNET program were investigated.
METHODS: The study was an LTFU of participants of the FITNET trial. Data were completed for 112 (88.2%) of 127 approached FITNET study participants. Primary outcomes were fatigue severity (Checklist Individual Strength–20), physical functioning (87-item Child Health Questionnaire), and school/work attendance.
RESULTS: After a mean follow-up of 2.7 years, 66 (58.9%) adolescents had recovered from CFS. Most adolescents who recovered directly after treatment with FITNET were still recovered at LTFU. At LTFU there was no difference between the recovery rates for the different treatment strategies (original randomization: FITNET [64%] versus any form of usual care [52.8%]). Per additional month of “pretreatment disease duration,” the odds for recovery were 4% lower (odds ratio: 0.96; 95% confidence interval: 0.93–0.99; P = .016), and per added point on “focus on bodily symptoms” (Body Consciousness Scale) of the mother (0–20 points) the odds for recovery were 11% lower (odds ratio: 0.89; 95% confidence interval: 0.80–0.99; P = .029).
CONCLUSIONS: The short-term effectiveness of Internet-based CBT on adolescent CFS is maintained at LTFU. At LTFU, usual care led to similar recovery rates, although these rates were achieved at a slower pace.
http://pediatrics.aappublications.org/content/early/2013/05/08/peds.2012-2007.abstract
 

Bob

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I haven't been paying attention to this study, or following this discussion, but it's been pointed out to me that 'usual care' consisted of the following:

Usual care
The patients in the control group will receive the usual care available in the region where the patient lives. The available usual care for adolescents with CFS in the Netherlands includes: individual/group based rehabilitation programs, psychological support including CBT face-to-face, graded exercise therapy by a physiotherapist, etc. All care received will be monitored during the study.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049137/

So does this mean that it can now be said that internet-based CBT is equivalent to face-to-face CBT, GET and 'rehabilitation' programs, etc?
 

Esther12

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This forum is now a substitute for my memory Bob. I search here to find out what I think about something.

The control group problem was discussed, but it all seems a bit redundant now that we know whatever differences there were disappeared at their follow-up point. The researchers are still trying to spin this as a big success though:

http://www.healio.com/pediatrics/ad...-term-chronic-fatigue-recovery-in-adolescents

Internet-based therapy led to long-term chronic fatigue recovery in adolescents

Nijhof SL. Pediatrics. 2013;doi:10.1542/peds.2012-2007.


  • May 31, 2013
Adolescent chronic fatigue treated with Internet-based cognitive-behavioral therapy effectiveness was maintained at long-term follow-up, according to recent study results published in Pediatrics.
“Compared with usual care, Internet-based [cognitive-behavioral therapy] treatment of adolescents led to earlier recovery from [chronic fatigue syndrome],” researchers wrote. “This shortened recovery period is crucial during adolescence, when school attendance and social contacts are crucial for social and academic development.”
The long-term follow-up study was of participants from the Fatigue in Teenagers on the Internet (FITNET) trial. Researchers completed data from 88.2% of participants from FITNET. They examined fatigue severity, physical functioning and school/work attendance.
Researchers found, after a mean follow-up of 2.7 years, 58.9% of adolescents recovered from chronic fatigue syndrome. According to researchers, most of the participants who recovered after FITNET were still recovered at follow-up.
Researchers also found that for each additional month of “pretreatment disease duration,” there was a 4% lower odd for recovery (OR=0.96; 95% CI, 0.93-0.99) and 11% lower odds for recovered for “focus on bodily symptoms” of the mother (OR=0.89; 95% CI, 0.80-0.99).
“The treatment effects of Internet-based [cognitive-behavioral therapy] persist at long-term follow-up,” researchers wrote. “A challenge remains to offer Internet-based [cognitive-behavioral therapy] in those cases that are most likely to benefit from it and to recognize situations that might require more intense forms of therapy.”
Disclosure: The researchers report no relevant financial disclosures.
 

Bob

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Thank you Esther. I can't remember a thing about this study, and I'm being a bit lazy because I can't be bothered to read up on it again.
But I think it was your earlier comments that prompted me to post my previous comment.
I seem to remember you saying that there was no difference between the treatment group and the control group?
So what I'm asking is, if there were no differences between the treatment group and the control group, would this have been considered a success, because the control group consisted of full treatments?
In other words FITNET proved to be as effective as other treatments?
 

Esther12

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Thank you esther. I can't remember a thing about this study, and I'm being a bit lazy because I can't be bothered to read up on it again. (I don't like to waste much time on biopsychosocial studies, esp as I don't seem to be able to remember a thing about them after I've read them!)
But I think it was your earlier comments that prompted me to post my previous comment.
I seem to remember you saying that there was no difference between the treatment group and the control group?
So what I'm asking is, if there were no differences between the treatment group and the control group, would this have been considered a success, because the control group consisted of full treatments?
In other words FITNET proved to be as effective as other treatments?
This is from memory, so be sceptical: I think that the control group involved 'usual care' and a lot of those in usual care (but not all) received some sort of CBT or GET.

The initial paper seemed to claim that the provision of FITNET led to really big improvements in recovery rates (it seemed a genuinely impressive result), but this was difficult to interpret, as the control group seemed to do unusually badly for teens (although I'm not sure exactly what we should expect here, and I think that we have less good evidence on natural course of 'CFS' for teens). I remember think that it was likely FITNET would be less prone to quackery than normal CBT, as both sides would have a clear record of what was said. Anyway, the follow up now shows no difference between treatment and control groups, so it seems likely it was just an example of additional treatment leading to people being more positive about symptoms in a way that had no real impact upon their health. The weird nature of the control group does make it really hard to say though. Maybe it shows how super-effective FITNET is, that CBT/GET take a bit more time to be super-effective, but that all these kids would have been permanently disabled without these fine interventions.

We need more attempts at placebo control with behavioural interventions. The trouble is that it seems no 'positive' behavioural intervention likely to capture the problems with response bias can be so quacky that it is recognised as not being of 'real' value to patients.
 

Bob

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New paper by some of the FITNET co-authors (it's not a FITNET paper, but I think perhaps it might cite the FITNET paper):

Clinical Practice: Chronic fatigue syndrome
Charlotte L. Werker, Sanne L. Nijhof, Elise M. van de Putte
June 2013
European Journal of Pediatrics
http://link.springer.com/article/10.1007/s00431-013-2058-8

Abstract
The diagnosis chronic fatigue syndrome (CFS) was conceptualized in the mid-1980s. It is a clinically defined condition characterized by severe and disabling new onset fatigue with at least four additional symptoms: impaired memory or concentration, sore throat, tender cervical or axillary lymph nodes, muscle pain, multi-joint pain, new headaches, unrefreshing sleep or post-exertion malaise. Chronic fatigue syndrome in adolescents is a rare condition compared to symptomatic fatigue. The estimated prevalence of adolescent CFS ranges between 0.11 and 1.29 % in Dutch, British, and US populations. Diagnosis of the chronic fatigue syndrome is established through exclusion of other medical and psychiatric causes of chronic fatiguing illness. Taking a full clinical history and a full physical examination are therefore vital. In adolescence, CFS is associated with considerable school absence with long-term detrimental effects on academic and social development. One of the most successful potential treatments for adolescents with CFS is cognitive behavioural therapy, which has been shown to be effective after 6 months in two thirds of the adolescents with CFS. This treatment effect sustains at 2–3-year follow-up. In conclusion, the diagnosis CFS should be considered in any adolescent patient with severe disabling long-lasting fatigue. Cognitive behavioural therapy is effective in 60–70 % of the patients. Prompt diagnosis favours the prognosis.

Separate thread:
http://forums.phoenixrising.me/inde...ice-chronic-fatigue-syndrome-june-2013.23759/
 

Bob

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Esther12, I've done a little reading on FITNET now. It seems that i hadn't read up about FITNET after all, which is why I couldn't remember any of the details. :confused:

As far as I understand it (I haven't read the papers or discussions in full) there are a number of weaknesses in the study, including: a post-hoc & questionable definition of recovery; a lack of objectively measured endpoints (e.g. actometers); the unusually low improvement rates for people receiving usual care; and the lack of a structured, well-defined or homogeneous control group. And of course, no placebo control, as always in these studies.

Looking at the FITNET long-term follow-up paper, the short-term improvements (aka 'recovery') seen in the FITNET group were mainly maintained at long-term follow-up, but there was no difference between the FITNET group and the usual care control group at long-term follow-up. (The control group had caught up with the FITNET group.)

This means, using their methodology, FITNET was demonstrated to have no effectiveness beyond the control group.

I think perhaps the results suggest that a high proportion of adolescents (who experience chronic fatigue, at least) are likely to see significant natural improvement over time. At best, FITNET appears to speed up the natural improvements, but this is questionable because of the lack of objective endpoints measures, instead relying of subjective questionnaire scores which can be influenced by the therapy, the therapists and parental involvement in the FITNET program.

The long-term follow-up (LTFU) paper abstract concludes:
“At LTFU, usual care led to similar recovery rates, although these rates were achieved at a slower pace.”

(I'm sure that you've all worked this out already, but I'm using this post to organise my thoughts!)
 

Bob

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Esther12

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Thanks Bob, and thanks for those comments.

The lack of difference between control and intervention group at follow up, combined with the history of spin from these authors, does mean that it's hard to be interested enough to take a close look at this study. It will be interested to see if it goes on to be cited as a CBT success story.
 

WillowJ

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Hi Willow,
Are you certain that it indicates that the NIH helped fund it?
I can't see any mention of a grant or funding.
I wonder if that website is just a registry for clinical trials?
hmm, that's a good question. you could be right. I guess I don't know.